The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Cap-one, Model Tg-920p.
| Device ID | K040875 |
| 510k Number | K040875 |
| Device Name: | CAP-ONE, MODEL TG-920P |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Serrah Namini |
| Correspondent | Serrah Namini NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-02 |
| Decision Date | 2004-10-15 |
| Summary: | summary |